Identity Imprint Knee Replacement System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Conformis Inc.

The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Identity Imprint Knee Replacement System.

Pre-market Notification Details

Device IDK210191
510k NumberK210191
Device Name:Identity Imprint Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis Inc. 600 Technology Park Drive Billerica,  MA  01821
ContactKara Johnson
CorrespondentKara Johnson
Conformis Inc. 600 Technology Park Drive Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M572TPS020187S011 K210191 000
M572TCR030103N011 K210191 000
M572TCR030102S011 K210191 000
M572TCR030084N011 K210191 000
M572TCR030083S011 K210191 000
M572TCR030083N011 K210191 000
M572TCR030082S011 K210191 000
M572TCR030074N011 K210191 000
M572TCR030073S011 K210191 000
M572TCR030073N011 K210191 000
M572TCR030072S011 K210191 000
M572TCR030103S011 K210191 000
M572TCR030104N011 K210191 000
M572TCR030122S011 K210191 000
M572TCR030163S011 K210191 000
M572TCR030162S011 K210191 000
M572TCR030162N011 K210191 000
M572TCR030144N011 K210191 000
M572TCR030143S011 K210191 000
M572TCR030143N011 K210191 000
M572TCR030142S011 K210191 000
M572TCR030124N011 K210191 000
M572TCR030123S011 K210191 000
M572TCR030123N011 K210191 000
M572TCR030064N011 K210191 000
M572TCR030063S011 K210191 000
M572TCR030063N011 K210191 000
M572TPS030165S011 K210191 000
M572TPS030165N011 K210191 000
M572TPS030164S011 K210191 000
M572TPS030164N011 K210191 000
M572TPS030163S011 K210191 000
M572TPS030161S011 K210191 000
M572TPS030147S011 K210191 000
M572TPS030146S011 K210191 000
M572TPS030146N011 K210191 000
M572TPS030145S011 K210191 000
M572TPS030166N011 K210191 000
M572TPS030166S011 K210191 000
M572TPS030167S011 K210191 000
M572TCR030062S011 K210191 000
M572TPS030187S011 K210191 000
M572TPS030186S011 K210191 000
M572TPS030186N011 K210191 000
M572TPS030185S011 K210191 000
M572TPS030185N011 K210191 000
M572TPS030184S011 K210191 000
M572TPS030184N011 K210191 000
M572TPS030183S011 K210191 000
M572TPS030181S011 K210191 000
M572TPS030145N011 K210191 000
M572TPS030062S011 K210191 000
M572TPS020146S011 K210191 000
M572TPS020076N011 K210191 000
M572TPS020067S011 K210191 000
M572TPS020066S011 K210191 000
M572TPS020066N011 K210191 000
M572TCR030161S011 K210191 000
M572TCR030142N011 K210191 000
M572TCR030141S011 K210191 000
M572TCR030122N011 K210191 000
M572TCR030121S011 K210191 000
M572TCR030102N011 K210191 000
M572TPS020076S011 K210191 000
M572TPS020077S011 K210191 000
M572TPS020086N011 K210191 000
M572TPS020146N011 K210191 000
M572TPS020145S011 K210191 000
M572TPS020127S011 K210191 000
M572TPS020126S011 K210191 000
M572TPS020126N011 K210191 000
M572TPS020125S011 K210191 000
M572TPS020106S011 K210191 000
M572TPS020106N011 K210191 000
M572TPS020087S011 K210191 000
M572TPS020086S011 K210191 000
M572TCR030101S011 K210191 000
M572TCR030082N011 K210191 000
M572TCR030081S011 K210191 000
M572TPS030122S011 K210191 000
M572TPS030122N011 K210191 000
M572TPS030103N011 K210191 000
M572TPS030102S011 K210191 000
M572TPS030083N011 K210191 000
M572TPS030082S011 K210191 000
M572TPS030073S011 K210191 000
M572TPS030073N011 K210191 000
M572TPS030072S011 K210191 000
M572TPS030063S011 K210191 000
M572TPS030123N011 K210191 000
M572TPS030142N011 K210191 000
M572TPS030142S011 K210191 000
M572TCR030072N011 K210191 000
M572TCR030071S011 K210191 000
M572TCR030062N011 K210191 000
M572TCR030061S011 K210191 000
M572TPS030182S011 K210191 000
M572TPS030182N011 K210191 000
M572TPS030163N011 K210191 000
M572TPS030162S011 K210191 000
M572TPS030162N011 K210191 000
M572TPS030143N011 K210191 000
M572TPS030063N011 K210191 000
M572TPS030144S011 K210191 000
M572TCR030167S011 K210191 000
M572TCR030126S011 K210191 000
M572TCR030126N011 K210191 000
M572TCR030125S011 K210191 000
M572TCR030125N011 K210191 000
M572TCR030124S011 K210191 000
M572TCR030107S011 K210191 000
M572TCR030106S011 K210191 000
M572TCR030106N011 K210191 000
M572TCR030105S011 K210191 000
M572TCR030105N011 K210191 000
M572TCR030127S011 K210191 000
M572TCR030144S011 K210191 000
M572TCR030145N011 K210191 000
M572TCR030166S011 K210191 000
M572TCR030166N011 K210191 000
M572TCR030165S011 K210191 000
M572TCR030165N011 K210191 000
M572TCR030164S011 K210191 000
M572TCR030164N011 K210191 000
M572TCR030147S011 K210191 000
M572TCR030146S011 K210191 000
M572TCR030146N011 K210191 000
M572TCR030145S011 K210191 000
M572TCR030104S011 K210191 000
M572TCR030087S011 K210191 000
M572TCR030086S011 K210191 000
M572TCR030065S011 K210191 000
M572TCR030065N011 K210191 000
M572TCR030064S011 K210191 000
M572TCR000D003011 K210191 000
M572TCR000D002011 K210191 000
M572TPS030183N011 K210191 000
M572TCR301T06N011 K210191 000
M572TPS020107S011 K210191 000
M572TPS000D00F021 K210191 000
M572TCR000D00T021 K210191 000
M572TCR030066N011 K210191 000
M572TCR030066S011 K210191 000
M572TCR030067S011 K210191 000
M572TCR030086N011 K210191 000
M572TCR030085S011 K210191 000
M572TCR030085N011 K210191 000
M572TCR030084S011 K210191 000
M572TCR030077S011 K210191 000
M572TCR030076S011 K210191 000
M572TCR030076N011 K210191 000
M572TCR030075S011 K210191 000
M572TCR030075N011 K210191 000
M572TCR030074S011 K210191 000
M572TCR000D00F021 K210191 000
M572TPS000D002011 K210191 000
M572TPS030144N011 K210191 000
M572TPS030106N011 K210191 000
M572TPS030105S011 K210191 000
M572TPS030105N011 K210191 000
M572TPS030104S011 K210191 000
M572TPS030104N011 K210191 000
M572TPS030103S011 K210191 000
M572TPS030102N011 K210191 000
M572TPS030101S011 K210191 000
M572TPS030087S011 K210191 000
M572TPS030086S011 K210191 000
M572TPS030106S011 K210191 000
M572TPS030107S011 K210191 000
M572TPS030121S011 K210191 000
M572TPS030143S011 K210191 000
M572TPS030141S011 K210191 000
M572TPS030127S011 K210191 000
M572TPS030126S011 K210191 000
M572TPS030126N011 K210191 000
M572TPS030125S011 K210191 000
M572TPS030125N011 K210191 000
M572TPS030124S011 K210191 000
M572TPS030124N011 K210191 000
M572TPS030123S011 K210191 000
M572TPS030086N011 K210191 000
M572TPS030085S011 K210191 000
M572TPS030085N011 K210191 000
M572TPS030071S011 K210191 000
M572TPS030067S011 K210191 000
M572TPS030066S011 K210191 000
M572TPS030066N011 K210191 000
M572TPS030065S011 K210191 000
M572TPS030065N011 K210191 000
M572TPS030064S011 K210191 000
M572TPS030064N011 K210191 000
M572TPS030062N011 K210191 000
M572TPS030061S011 K210191 000
M572TPS030072N011 K210191 000
M572TPS030074N011 K210191 000
M572TPS030074S011 K210191 000
M572TPS030084S011 K210191 000
M572TPS030084N011 K210191 000
M572TPS030083S011 K210191 000
M572TPS030082N011 K210191 000
M572TPS030081S011 K210191 000
M572TPS030077S011 K210191 000
M572TPS030076S011 K210191 000
M572TPS030076N011 K210191 000
M572TPS030075S011 K210191 000
M572TPS030075N011 K210191 000
M572TPS000D003011 K210191 000
M572TPS020147S011 K210191 000
M572TCR020143N011 K210191 000
M572TCR020083S011 K210191 000
M572TCR020083N011 K210191 000
M572TCR020082S011 K210191 000
M572TCR020082N011 K210191 000
M572TCR020081S011 K210191 000
M572TCR020073S011 K210191 000
M572TCR020073N011 K210191 000
M572TCR020072S011 K210191 000
M572TCR020072N011 K210191 000
M572TCR020071S011 K210191 000
M572TCR020101S011 K210191 000
M572TCR020102N011 K210191 000
M572TCR020102S011 K210191 000
M572TCR020142S011 K210191 000
M572TCR020142N011 K210191 000
M572TCR020141S011 K210191 000
M572TCR020123S011 K210191 000
M572TCR020123N011 K210191 000
M572TCR020122S011 K210191 000
M572TCR020122N011 K210191 000
M572TCR020121S011 K210191 000
M572TCR020103S011 K210191 000
M572TCR020103N011 K210191 000
M572TCR020063S011 K210191 000
M572TCR020063N011 K210191 000
M572TCR020062S011 K210191 000
M572TCR020085N011 K210191 000
M572TCR020084S011 K210191 000
M572TCR020084N011 K210191 000
M572TCR020075N011 K210191 000
M572TCR020074S011 K210191 000
M572TCR020074N011 K210191 000
M572TCR020065N011 K210191 000
M572TCR020064S011 K210191 000
M572TCR020064N011 K210191 000
M572TPS020182N011 K210191 000
M572TCR020104N011 K210191 000
M572TCR020104S011 K210191 000
M572TCR020105N011 K210191 000
M572TCR020062N011 K210191 000
M572TCR020061S011 K210191 000
M572TCR020164S011 K210191 000
M572TCR020164N011 K210191 000
M572TCR020163S011 K210191 000
M572TCR020144S011 K210191 000
M572TCR020144N011 K210191 000
M572TCR020143S011 K210191 000
M572TCR020124S011 K210191 000
M572TCR020124N011 K210191 000
M572TPS020181S011 K210191 000
M572TCR020161S011 K210191 000
M572TPS301T07S011 K210191 000
M572TPS101F06N011 K210191 000
M572TPS101F05S011 K210191 000
M572TPS101F05N011 K210191 000
M572TPS101F04S011 K210191 000
M572TPS101F04N011 K210191 000
M572TPS101F03S011 K210191 000
M572TPS101F03N011 K210191 000
M572TPS101F02S011 K210191 000
M572TPS101F02N011 K210191 000
M572TPS101F01S011 K210191 000
M572TPS101F06S011 K210191 000
M572TPS101F07S011 K210191 000
M572TPS301T01S011 K210191 000
M572TPS301T06S011 K210191 000
M572TPS301T06N011 K210191 000
M572TPS301T05S011 K210191 000
M572TPS301T05N011 K210191 000
M572TPS301T04S011 K210191 000
M572TPS301T04N011 K210191 000
M572TPS301T03S011 K210191 000
M572TPS301T03N011 K210191 000
M572TPS301T02S011 K210191 000
M572TPS301T02N011 K210191 000
M572TCR301T07S011 K210191 000
M572TCR301T06S011 K210191 000
M572TCR301T06N01 K210191 000
M572TCR101F05N011 K210191 000
M572TCR101F04S011 K210191 000
M572TCR101F04N011 K210191 000
M572TCR101F03S011 K210191 000
M572TCR101F03N011 K210191 000
M572TCR101F02S011 K210191 000
M572TCR101F02N011 K210191 000
M572TCR101F01S011 K210191 000
M572TCR020163N011 K210191 000
M572TCR020162S011 K210191 000
M572TCR101F05S011 K210191 000
M572TCR101F06N011 K210191 000
M572TCR101F06S011 K210191 000
M572TCR301T05S011 K210191 000
M572TCR301T05N011 K210191 000
M572TCR301T04S011 K210191 000
M572TCR301T04N011 K210191 000
M572TCR301T03S011 K210191 000
M572TCR301T03N011 K210191 000
M572TCR301T02S011 K210191 000
M572TCR301T02N011 K210191 000
M572TCR301T01S011 K210191 000
M572TCR101F07S011 K210191 000
M572TCR020162N011 K210191 000
M572TPS020162S011 K210191 000
M572TPS020185N011 K210191 000
M572TPS020143N011 K210191 000
M572TPS020125N011 K210191 000
M572TPS020124S011 K210191 000
M572TPS020124N011 K210191 000
M572TPS020123S011 K210191 000
M572TPS020123N011 K210191 000
M572TPS020105S011 K210191 000
M572TPS020105N011 K210191 000
M572TPS020104S011 K210191 000
M572TPS020104N011 K210191 000
M572TPS020143S011 K210191 000
M572TPS020144N011 K210191 000
M572TPS020144S011 K210191 000
M572TPS020184S011 K210191 000
M572TPS020184N011 K210191 000
M572TPS020183S011 K210191 000
M572TPS020183N011 K210191 000
M572TPS020165N011 K210191 000
M572TPS020164S011 K210191 000
M572TPS020164N011 K210191 000
M572TPS020163S011 K210191 000
M572TPS020163N011 K210191 000
M572TPS020145N011 K210191 000
M572TPS020103S011 K210191 000
M572TPS020103N011 K210191 000
M572TPS020085S011 K210191 000
M572TPS020064S011 K210191 000
M572TPS020064N011 K210191 000
M572TPS020063S011 K210191 000
M572TPS020063N011 K210191 000
M572TPS020186S011 K210191 000
M572TPS020186N011 K210191 000
M572TPS020185S011 K210191 000
M572TPS020167S011 K210191 000
M572TPS020166S011 K210191 000
M572TPS020166N011 K210191 000
M572TPS020065N011 K210191 000
M572TPS020065S011 K210191 000
M572TPS020073N011 K210191 000
M572TPS020085N011 K210191 000
M572TPS020084S011 K210191 000
M572TPS020084N011 K210191 000
M572TPS020083S011 K210191 000
M572TPS020083N011 K210191 000
M572TPS020075S011 K210191 000
M572TPS020075N011 K210191 000
M572TPS020074S011 K210191 000
M572TPS020074N011 K210191 000
M572TPS020073S011 K210191 000
M572TPS020165S011 K210191 000
M572TCR020067S011 K210191 000
M572TPS020162N011 K210191 000
M572TPS020072S011 K210191 000
M572TPS020072N011 K210191 000
M572TPS020062S011 K210191 000
M572TPS020062N011 K210191 000
M572TPS020061S011 K210191 000
M572TCR020166N011 K210191 000
M572TCR020165S011 K210191 000
M572TCR020165N011 K210191 000
M572TCR020146N011 K210191 000
M572TCR020145S011 K210191 000
M572TPS020081S011 K210191 000
M572TPS020082N011 K210191 000
M572TPS020082S011 K210191 000
M572TPS020161S011 K210191 000
M572TPS020142S011 K210191 000
M572TPS020142N011 K210191 000
M572TPS020141S011 K210191 000
M572TPS020122S011 K210191 000
M572TPS020122N011 K210191 000
M572TPS020121S011 K210191 000
M572TPS020102S011 K210191 000
M572TPS020102N011 K210191 000
M572TPS020101S011 K210191 000
M572TCR020145N011 K210191 000
M572TCR020126N011 K210191 000
M572TCR020125S011 K210191 000
M572TCR020167S011 K210191 000
M572TCR020166S011 K210191 000
M572TCR020147S011 K210191 000
M572TCR020146S011 K210191 000
M572TCR020127S011 K210191 000
M572TCR020126S011 K210191 000
M572TCR020107S011 K210191 000
M572TCR020106S011 K210191 000
M572TCR020087S011 K210191 000
M572TCR020086S011 K210191 000
M572TPS020071S011 K210191 000
M572TPS020182S011 K210191 000
M572TCR020065S011 K210191 000
M572TCR020125N011 K210191 000
M572TCR020106N011 K210191 000
M572TCR020105S011 K210191 000
M572TCR020086N011 K210191 000
M572TCR020085S011 K210191 000
M572TCR020076S011 K210191 000
M572TCR020076N011 K210191 000
M572TCR020075S011 K210191 000
M572TCR020066S011 K210191 000
M572TCR020066N011 K210191 000
M572TCR020077S011 K210191 000
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.